D-0244-2019 Class II Terminated
FDA drug recall D-0244-2019 was initiated by Teva Pharmaceuticals USA on Sep 27, 2018 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing The recall status is terminated (terminated Oct 6, 2020). Affected quantity: 1,362 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 21, 2018
- Initiation Date
- Sep 27, 2018
- Termination Date
- Oct 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,362 vials
Product Description
Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA, Inc., North Wales, PA --- NDC 0703-1501-02
Reason for Recall
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Distribution Pattern
Product was distributed throughout the United States, including Hawaii and Puerto Rico.
Code Information
Lot # 31323147B, exp. date 01/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0244-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026